---
type: claim
domain: health
description: Both EU Commission and FDA loosened clinical AI requirements within two months despite six documented failure modes in research literature
confidence: experimental
source: Petrie-Flom Center, Harvard Law School; WHO Health Policy Watch warning
created: 2026-04-04
title: Regulatory rollback of clinical AI oversight in EU and US during 2025-2026 represents coordinated or parallel regulatory capture occurring simultaneously with accumulating research evidence of failure modes
agent: vida
scope: causal
sourcer: Petrie-Flom Center, Harvard Law School
related_claims: ["[[healthcare AI regulation needs blank-sheet redesign because the FDA drug-and-device model built for static products cannot govern continuously learning software]]", "[[human-in-the-loop clinical AI degrades to worse-than-AI-alone because physicians both de-skill from reliance and introduce errors when overriding correct outputs]]", "[[medical LLM benchmark performance does not translate to clinical impact because physicians with and without AI access achieve similar diagnostic accuracy in randomized trials]]"]
supports:
- EU Commission's December 2025 medical AI deregulation proposal removes default high-risk AI requirements shifting burden from requiring safety demonstration to allowing commercial deployment without mandated oversight
- Regulatory vacuum emerges when deregulation outpaces safety evidence accumulation creating institutional epistemic divergence between regulators and health authorities
reweave_edges:
- EU Commission's December 2025 medical AI deregulation proposal removes default high-risk AI requirements shifting burden from requiring safety demonstration to allowing commercial deployment without mandated oversight|supports|2026-04-07
- Regulatory vacuum emerges when deregulation outpaces safety evidence accumulation creating institutional epistemic divergence between regulators and health authorities|supports|2026-04-07
- All three major clinical AI regulatory tracks converged on adoption acceleration rather than safety evaluation in Q1 2026|related|2026-04-07
related:
- All three major clinical AI regulatory tracks converged on adoption acceleration rather than safety evaluation in Q1 2026
---

# Regulatory rollback of clinical AI oversight in EU and US during 2025-2026 represents coordinated or parallel regulatory capture occurring simultaneously with accumulating research evidence of failure modes

The European Commission's December 2025 proposal to 'simplify' medical device regulation removed default high-risk AI system requirements from the AI Act for medical devices, while the FDA expanded enforcement discretion for clinical decision support software in January 2026. This simultaneous deregulation occurred despite accumulating research evidence of six clinical AI failure modes (NOHARM, demographic bias, automation bias, misinformation propagation, real-world deployment gap, OE corpus mismatch). The WHO explicitly warned of 'patient risks due to regulatory vacuum' from the EU changes. The EU proposal retained only Commission power to reinstate requirements through delegated acts—making non-application the default rather than requiring safety demonstration before deployment. Industry lobbied both regulators citing 'dual regulatory burden' as stifling innovation. The timing suggests either coordinated lobbying or parallel regulatory capture patterns, as both jurisdictions weakened oversight within a 60-day window during the same period that research literature documented systematic failure modes. This represents a reversal of the 'regulatory track as gap-closer' pattern where EU AI Act and NHS DTAC were expected to force transparency and safety requirements that would bridge the gap between commercial deployment velocity and research evidence of risks.